Anteris Technologies

Quality Engineer II

Maple Grove, Minnesota, United States · Mid

No sponsorship$88k-$108kDetected 22 days ago

StatisticsComplianceProcess ImprovementGMPFDA RegulatoryMedical DevicesWriting

About the role

With offices in Minneapolis, MN, US; Geneva, Switzerland; and Brisbane and Perth, Australia, we have a growing and inclusive team.

Partner with R&D, Design, Process, and Manufacturing Engineering to develop and execute product and process validation strategies.
Support delivery system manufacturing processes, including product quality activities.
Participate in cross-functional mRB discussions and support nonconformance invesigations, including CAPAs and customer complaints.
Develop sampling plans and approve inspection methods for in-process and finished product acceptance.
Review and support execution of validation activities including IQ, OQ, PQ, TMV, and software validation
Support resolution of complex technical issues related to manufacturing processes
Ensure compliance with applicable regulatory standards (e.g., FDA CFR 820, ISO 13485, ISO 14971) and support audit readiness and execution
Maintain and assess effectiveness of CAPAs and quality system processes
Develop and maintain process monitoring and control strategies aligned to product and process risk
Support development and maintenance of quality documentation, including control plans, work instructions, and inspection methods

Bachelor's degree in Engineering, Physical Science, or related discipline
Experience supporting process validation, risk management, nonconformance handling, and process improvement in regulated environments
Working knowledge of FDA CFR 820, ISO 13485, and ISO 14971
Experience with product and process verification and validation activities

Master's degree in Engineering or related field
Experience with valve manufacturing or biological tissue products
Familiarity with ISO 5840 standards
Strong knowledge of inspection methods and measurement systems
Experience with statistical tools, DOE, and process capability analysis
Certifications such as ASQ CQE, Six Sigma, or CQA
Demonstrated ability to solve complex problems and contribute in a fast-paced, cross-functional environment
Experience with requirements management tools (e.g., Jama Connect)

Anteris® Technologies is a global structural heart company dedicated to revolutionizing cardiac care.
Today, younger, more active patients need a better solution that will not just open and close but restore healthy heart function.

$88,000 - $108,000 USD
Diversity is more than a commitment - it is part of our mission to deliver the best structural heart products on a global scale.
Target base salary range: $88,000 - $108,000, plus eligibility for an annual short-term incentive (STI) targeted at 7% of base salary and equity participation.
Final compensation will be determined based on experience and alignment with role requirements.
Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.
What We Offer:

Opportunity to make a significant impact on the healthcare industry by advancing groundbreaking therapies.
Competitive compensation package, including salary, performance-based bonuses, and stock options.
Our Health and Wellness Offerings:
Medical, Dental, and Vision Offerings
Flexible Spending Account (FSA)
Life, AD&D, Short Term and Long-Term Disability Insurance
Bonus Plan Eligibility
Employee Equity Program

Career development opportunities and a chance to be part of a growing company that values its employees.

Unfortunately, we are unable to sponsor work visas (OPT, H1B, etc.) at this time.

This listing is sourced directly from Anteris Technologies's careers page and normalized into a canonical job model.